About this trial
This randomized, double-blind, parallel, placebo-controlled phase Ⅲ study to evaluate the efficacy and safety of UBT251 Injection in overweight/obese patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years (inclusive) at the time of signing the informed consent form, regardless of gender;
Body mass index (BMI) ≥28.0 kg/m² (obesity) or 24.0 kg/m² ≤ BMI <28.0 kg/m² (overweight) at screening, accompanied by by at least one of the following: a. Prediabetes, hypertension, dyslipidemia, or fatty liver; b. Weight-bearing joint pain; c. Obesity-induced dyspnea or obstructive sleep apnea syndrome;
Self-reported having been on diet and exercise control for 3 months or more prior to screening, with body weight change ≤5 kg within the past 3 months;
Trial participants (including their partners) have no plan for pregnancy from screening to 6 months after trial completion, and are willing to comply with the contraceptive measures specified in the trial, and have no plan for sperm or egg donation within 6 months after trial completion;
Disqualifiers
Known history of hypersensitivity to this study drug, its drug product excipients, or other similar active drugs;
Treatment with dipeptidyl peptidase-4 (DPP-4) inhibitors, amylin analogs, glucagon-like peptide-1 (GLP-1) analogs, glucose-dependent insulinotropic polypeptide (GIP) analogs, or glucagon (GCG) analogs;
Use of over-the-counter weight-loss medications or appetite suppressants (including traditional Chinese medicine, dietary supplements, meal replacements), or prescription weight-loss medications (including but not limited to orlistat) or lipolytic injections (e.g., fat-dissolving injections);
Use of medications that may affect body weight for a duration of 1 week or longer, or anticipated use during the trial, including but not limited to systemic glucocorticoid therapy (intravenous or oral administration, except for the following: topical external use or intra-articular, intranasal, ophthalmic, and inhaled glucocorticoids; short-term [≤7 days] systemic glucocorticoid use for prevention or treatment of non-autoimmune allergic diseases, upper respiratory tract infection);
Trial design
Parallel
Treatments tested in this trial
UBT251 Injection 4.0 mg
DrugUBT251 Injection subcutaneously once weekly
UBT251 Injection 6.0 mg
DrugUBT251 Injection and UBT251 Injection Placebo subcutaneously once weekly
UBT251 Injection Placebo 4.0 mg
DrugUBT251 Injection placebo subcutaneously once weekly
UBT251 Injection Placebo 6.0 mg
DrugUBT251 Injection placebo subcutaneously once weekly
Treatment groups
Trial outcomes
Primary outcomes
Body Weight
Percentage change in body weight from baseline after 52 weeks of treatment
Secondary outcomes
Waist Circumference
Changes from baseline in waist circumference at each visit
BMI
Changes from baseline in BMI at each visit
Systolic blood pressure
Changes from baseline in systolic blood pressure at each visit
Diastolic blood pressure
Changes from baseline in diastolic blood pressure at each visit
Sponsors and contacts
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